Hyoscyamine Sulfate .125 mg/5mL
Hyoscyamine Sulfate · ELIXIR · Chartwell RX, LLC
Hyoscyamine Sulfate is a elixir containing hyoscyamine sulfate at .125 mg/5mL, taken oral. Manufactured by Chartwell RX, LLC.
Key Facts
- Brand Name
- Hyoscyamine Sulfate
- Generic Name
- Hyoscyamine Sulfate
- NDC Code (Product)
62135-511- Manufacturer
- Chartwell RX, LLC
- Strength
- .125 mg/5mL
- Dosage Form
- ELIXIR
- Route
- ORAL
- Marketing Status
- Marketing Start
- 07/20/2022
Recall History
Aidapak Services, LLC
Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.
Physicians Total Care, Inc.
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Burel Pharmaceuticals Inc
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Virtus Pharmaceuticals, Llc
Chemical Contamination: Bottles may contain broken dessicants
Viatris Inc
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Vilvet Pharmaceuticals Inc.
cGMP deviations
West-ward Pharmaceutical Corp.
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Aidapak Services, LLC
Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl, Capsule, 10 mg, NDC 16714035103, Pedigree: W003613, EXP: 6/25/2014.
VIRTUS PHARMACEUTICALS OPCO II L
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Burel Pharmaceuticals Inc
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Dosage & Administration
DOSAGE AND ADMINISTRATION The dosage of Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets - Adults: One or two Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets three or four times a day according to condition and severity of symptoms.
Warnings
WARNINGS Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work. Phenobarbital may decrease the e…
Contraindications
CONTRAINDICATIONS glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis; in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.
Drug Interactions
Drug Interactions Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.
Adverse Reactions
ADVERSE REACTIONS Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations; and decreased sweating. Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the…
Frequently Asked Questions
What is Hyoscyamine Sulfate used for?
Hyoscyamine Sulfate contains Hyoscyamine Sulfate. It is a elixir taken oral. Consult your doctor for specific uses.
Is Hyoscyamine Sulfate a controlled substance?
Hyoscyamine Sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Hyoscyamine Sulfate?
The generic name for Hyoscyamine Sulfate is Hyoscyamine Sulfate. There are 4 other brand versions of Hyoscyamine Sulfate.
What is the NDC code for Hyoscyamine Sulfate .125 mg/5mL?
The NDC (National Drug Code) for Hyoscyamine Sulfate .125 mg/5mL is 62135-511, listed by Chartwell RX, LLC.